1. Field of Invention
The present invention relates to novel methods for stopping hemorrhaging of percutaneous wounds. The method comprises placement of a purse-string monofilament suture around the wound, insertion of the free two ends of the suture through a tension collar, manual tightening of the tension collar until hemostasis is achieved, and application of a suture lock to the free ends of the suture to secure the tension collar and maintain hemostasis. After a sufficient period of time for complete hemostasis, the suture lock and the tension collar are loosened; if hemostasis has been achieved, the suture lock, the tension collar, and the suture material are removed. If bleeding continues from the wound, the tension collar is tightened and the suture lock reapplied. This process may be repeated until complete hemostasis is achieved, without the need for additional suturing or manual compression. The present invention further relates to novel kits and devices for producing hemostasis of a percutaneous wound in an animal.
2. Background
Manual compression is used to obtain hemostasis of percutaneous wounds, including the puncture site following removal of vascular sheaths, catheters, and other devices used for percutaneous interventions. An effective device for obtaining puncture site hemostasis without manual compression would represent a substantial saving in physician time and improved efficiency in patient care. Such factors are of considerable importance to patients who must undergo repeated interventions, such as those receiving dialysis shunts (grafts and fistulae), and most especially those required to simultaneously take anticoagulants. Prolonged manual compression of 30–60 minutes is often required when anticoagulants such as heparin or large sheaths are used. Moreover, manual compression itself may compromise blood flow through the dialysis shunt, leading to clot formation. Similar considerations of time and efficiency apply to the need for wound closure of, for example, wounds caused by puncture, gunshot, or other roughly circular injury.
Various techniques of suture closure have been described to facilitate hemostasis at the puncture site. Many physicians have used the purse-string technique to achieve hemostasis. Although effective, the suture can be very difficult to remove because the knot tends to get buried within the tissues around the puncture sites, which can become quite puckered. The suture knot is then just a few millimeters away from the high flow hemodialysis vascular access and hemodialysis nurses are often reluctant to remove the sutures at the next dialysis session. Patients returning weeks to months after purse-string suture insertion for follow-up interventions would still have the previous sutures left in place. Thus, there is an acute need for a method that makes suture removal simple and safe, and wherein the patient does not have any suture material remaining.
Previously reported techniques for obtaining hemostasis following percutaneous intervention or injury include purse-string sutures with a temporary knot, a tourniquet device, or a hemostat to tighten the purse-string suture (see Vorwerk, Konner, Schurmann, and Gunther, a Simple Trick to Facilitate Bleeding Control after Percutaneous Hemodialysis Fistula and Graft Interventions, Cardiovasc Intervent Radiol 20(2):159–60 (1997); Zaleski, Funaki, Gentile, and Garofalo, Purse-string Sutures and Miniature Tourniquet to Achieve Immediate Hemostasis of Percutaneous Grafts and Fistulas: a Simple Trick with a Twist, Am. J. Roentgenol. 175(6):1643–5 (2000); and Simons, Clark, and Rajan, The Woggle Technique: A New Method of Suture Closure of Hemodialysis Arteriovenous Grafts and Fistulae After Percutaneous Intervention, Journal of Vascular and Interventional Radiology 12(1):S30 (2001)). A temporary knot fails to allow a means of providing rapid and reversible tension on the puncture site. A tourniquet device passes through a loop of purse-string suture and achieves hemostasis through twisting and traction of the skin at the puncture site.
U.S. Pat. No. 6,355,050, issued to Andreas, et al., on Mar. 12, 2002 discloses a device and method for suturing a tissue layer having two sides by releasably retaining at least a portion of the suture in a stationary position on one side of the tissue layer, wherein the portion of the suture is retrieved through the tissue layer from the opposite side whereby the suture is drawn from one side to the opposite side; in particular, Andreas, et al., disclose devices and methods for suturing the wall of a tubular graft and a graft anastomosis assembly.
U.S. Pat. No. 6,117,145, issued to Wood, et al., on Sep. 12, 2000, discloses a method and device for providing hemostasis at vascular penetration sites utilizing a blood vessel puncture occlusion device.
U.S. Pat. No. 6,036,699, issued to Andreas, et al. on Mar. 14, 2000, discloses medical devices and methods for suturing tissue by proximally drawing sutures through a tissue layer in the proximity of an aperture; suturing vascular tissue while maintaining adequate perfusion or hemostasis, or both; anastomosing a graft to an aperture in a vessel wall while maintaining hemostasis at the anastomosis with physiological flow and/or pressure in the vessel lumen; punching and removing tissue to form an aperture in a vessel wall while maintaining hemostasis at the aperture with physiological flow and/or pressure in the vessel lumen; automatically and repeatably placing suture thread through vessel wall tissue surrounding an aperture in the vessel wall in a suture pattern that is useful for anastomosing a tubular graft to the aperture; and, deploying a suture with one end extending through the tissue that surrounds a punched aperture in a vessel wall and the opposite suture end extending radially through a tubular graft wall adjacent an open end of the graft, such that a vessel anastomosis may be rapidly and repeatably performed in a CABG procedure even while the vessel is under physiological flow.
U.S. Pat. Nos. 6,015,428, 5,741,301, and 5,895,393, issued to Pagedas, respectively disclose an integrally formed suture and suture lock, a self locking suture lock, and a suture lock holder.
Statistically, the need for improved hemostasis devices is demonstrated by the number of prevalent patients in the United States with end-stage renal disease, which is expected to increase from 326,000 in 1998 to over 666,000 by 2010. Most of these patients will receive renal replacement therapy through hemodialysis. For a large portion of these patients, percutaneous access will be necessary to maintain dialysis shunt function. These patients also require ongoing periodic radiologic treatments with angioplasty balloons, stents, and clot removal devices to maintain dialysis shunt function. According to the United States Renal Data System, Medicare expenditures on dialysis access totaled nearly 1 billion dollars in 1994. Since that time, progressive escalation in the number of dialysis interventions has occurred. From 1991 to 1998, a 65% increase in prevalent dialysis patients was observed with a 100% increase in shunt blood clot removal procedures (declots) and a 65% increase in angioplasty and other procedures (revisions).
The duration of bleeding is highly variable among patients and depends on many factors, including the size of the vascular sheath used for the treatment procedure, the dose and elimination of heparin and other blood thinning agents, the anatomy of the patient, and the hemodynamic pressure within the dialysis shunt. Because patients will differ in bleeding tendency, a simple and effective means of reapplying tension to the puncture site is highly advantageous.
The prior art tourniquet devices pass through a single loop of purse-string suture and achieve hemostasis through twisting and traction of the skin at the puncture site. This produces unnecessary distortion of the puncture site, which, in Applicant's experience, leads to rebleeding once the tourniquet has been loosened. The present inventive methods and devices provide uniform, circumferential tension around the puncture site and can be quickly reapplied when necessary, while producing minimal distortion or traction on the skin.
Further, by removing the suture the same day as the surgery, there is a decreased risk of infection when compared to leaving in a suture for several days. When using the methods of the present invention, the requirements for coagulation testing prior to intervention may be relaxed. In patients with elevated INR, we have successfully performed interventions without complication, although we leave the hemostasis device on longer.
Thus, the present invention provides a simple, rapid method for obtaining a puncture site hemostasis following percutaneous intervention or injury, particularly of dialysis shunts and the like. The inventive methods provide uniform, circumferential tension around the puncture site and can be quickly reapplied when necessary. The potential benefits and advantages over existing techniques include rapid and reversible tension on the puncture site, reduced twisting and traction of the skin at the puncture site, and reduced physician intervention and improved efficiency in patient care resulting lower cost of medical care. Further, the inventive methods consistently obviate the need for follow-up appointments to remove a purse-string suture at a later date.